Specialty Pharmacy Insights

503A is a section of the Federal Food, Drug, and Cosmetic Act that regulates pharmacy compounding practices. Generally, 503A refers to “traditional” pharmacy compounding and specifies when traditional compounding pharmacies are permitted to compound and distribute drugs, the quantity they are permitted to compound, and compounding for office-use.

503A compounding is a rigorous process, which is why Avella employs highly-trained pharmacists and maintains compliance with USP<800> throughout our multiple compounding facilities. USP <800> applies to the handling of hazardous drugs during receipt, storage, compounding, dispensing, administration, and disposal and affects all healthcare workers who perform these activities. Our pharmacy staﬀ has extensive experience in producing these high-risk compounds and is skilled in providing clinical guidance to our customers.

Due to the complex nature of 503A compounding, with Avella’s services, hospitals and practices can outsource these medications without the need to build and staﬀ a facility that complies with these complex standards. This helps to reduce pharmacy overhead and free up resources. We invite you to watch our video to learn more about our 503A services.

At Avella, we take pride in our commitment to the highest quality standards. Our customers can count on best-in-class patient care, safety and quality thanks to our proprietary ordering, dosing and pathway compliance software, Logics+, which ensures accuracy throughout these processes. Because we compound overnight, we’re able to prepare, pack and ship orders the same day. So, our customers always get the right amount of medication at the right time.

503A compounding is just one way Avella is serving our patients and providers nationwide with medications and care held to the highest quality standards.